16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HARDYDISK NETILMICIN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 19, 2019
FRONT-LOAD POLYPROPYLENE SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
KRONNER LOW PROFILE SCOPE HOLDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code NGT·August 21, 2019
Span-America
FDA UDI
SPAN-AMERICA MEDICAL SYSTEMS, INC.·H93300266300000·ZIMMER LAM ARM CRADLE 12/CS
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·March 30, 2026
VERSAPOINT
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HIH·March 13, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 9, 2011
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 8, 2008
BD PRE-FILLED POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 26, 2019
SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code NGT·October 17, 2019
Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Beaver Visitec·July 11, 2018
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018